The Low Energy Neurofeedback System Is Now A FDA Certified Medical Device

In the latest neurofeedback news, Len Ochs, Ph.D. announced on April 24th in a private professional user group that the The Low Energy Neurofeedback System (LENS) is now a Food and Drug Administration (FDA) certified medical device. Dr. Ochs is the inventor of and a professional trainer of LENS.

Dr. Ochs described this new development as follows:

It [LENS] is an FDA-certified Class II medical device. It is “510K exempt.” The “Class II 510K exempt” medical device classification is a less restrictive certification than a 510-K certification, meaning that it is considered by the FDA as safer than the 510-K devices – which includes most other biofeedback and neurofeedback devices. The FDA notification letter immediately allows us to market the LENS as a biofeedback device for relaxation and self-regulation. How it is used is a function of what the provider’s licensing board allows.

LENS is an intriguing treatment approach, and hopefully future articles on the LENS technology will be posted to The Behavioral Medicine Report. In the mean time, here are a few resources for those who want to learn more about LENS: